Efficacy and Safety of Navitor Versus Sapien Valves in Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis.

Transcatheter aortic valve implantation (TAVI) has become an established treatment option for symptomatic severe aortic stenosis, particularly in older patients. In this meta-analysis, we compare the latest generations of self-expandable valves, Navitor (Abbott Structural Heart, Santa Clara, CA, USA), with balloon-expandable valves, Sapien (Edwards Lifesciences, Irvine, CA, USA), in TAVI. We systematically searched PubMed, Scopus, Web of Science, and Cochrane Library databases. Studies were considered eligible if they compared Navitor with Sapien valves in TAVI. Our search strategy yielded four studies with a total of 4,828 patients. In terms of safety and efficacy, no statistically significant differences were noted between the two groups in device and technical success, 30-day all-cause mortality, stroke incidence, or major vascular complications. Permanent pacemaker implantation (PPI) (risk ratio (RR) 2.16; 95% CI 1.67 to 2.80; P < 0.001) and moderate-to-severe paravalvular leakage (PVL) (RR 3.36; 95% CI 1.93 to 5.82; P < 0.001) rates were significantly higher in Navitor valve patients. In contrast, Navitor was associated with lower rates of moderate-to-severe patient-prosthesis mismatch (PPM) (RR 0.55; 95% CI 0.31 to 0.98; P = 0.043) and better hemodynamic outcomes compared to Sapien. In summary, both Navitor and Sapien valves were effective and safe in TAVI. However, the Navitor valve was associated with higher rates of moderate-to-severe PVL and PPI. On the other hand, Navitor had a better hemodynamic profile and lower moderate-to-severe PPM than Sapien.